FDA.reportPublic FDA data

Antiseptic Towelette

Manufacturer
GFA Production (Xiamen) Co., Ltd.
Effective date
2025-01-22
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 20:42:01

Label at a glance#

ProductAntiseptic Towelette
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Dosage and administration

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose:

OTC - PURPOSE SECTION

First Aid Antiseptic

Use:

INDICATIONS & USAGE SECTION

For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Warnings:

WARNINGS SECTION

For external use only.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

Do not use:

OTC - DO NOT USE SECTION

In the eyes, or over large areas of the body.

Directions:

DOSAGE & ADMINISTRATION SECTION

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Purified water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-002ANTISEPTIC TOWELETTE (BENZALKONIUM CHLORIDE) SWAB [GFA PRODUCTION (XIAMEN) CO., LTD.]9Legacy NDC20250123_f8db57a8-ffbe-4b77-bae0-287f31c36e37.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50814-00250814-002-01, 50814-002-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FAK Care4 Bus and School Yellow ORM DBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.3b5d07c6-bda2-4bc7-89b8-88280d11ed742025-01-22WarningsExact identifier
ndc (package): 50814-002-01
ndc11 (package): 50814000201
2c4d06ff-9f78-48ac-e063-6394a90a6b9df8db57a8-ffbe-4b77-bae0-287f31c36e372025-01-22WarningsExact identifier
spl id: 2c4d06ff-9f78-48ac-e063-6394a90a6b9d
spl set id: f8db57a8-ffbe-4b77-bae0-287f31c36e37

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.